Using Artificial Intelligence-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard. The primary aim of this study is to show the accuracy of intracolonoscopy AI-assisted optical diagnosis (CADx; autonomous or with human input) when the AI-assisted optical diagnosis made by the expert endoscopists is used as the reference standard. The specific aims are: 1. To evaluate the accuracy of intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) by comparing it to the obtained optical histology diagnoses provided by two independent expert endoscopists as the reference standard. 2. To evaluate the agreement between the intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) and the AI-assisted optical diagnosis performed by two independent expert endoscopists. 3. To determine whether AI-assisted optical polyp diagnosis for diminutive (1-5 mm) polyps can be implemented in routine clinical practice by demonstrating that at least 70% of the approached patients are interested in undergoing AI-assisted optical diagnosis (autonomous or with human input). 4. To evaluate the cost savings resulting from replacing pathology with AI-assisted optical diagnosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 45-80 years

• Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Université de Montréal (CHUM)

• Signed informed consent form

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 204
Treatments
Other: AI-assisted classification with endoscopist's input
AI-assisted classification for diminutive polyps during a colonoscopy procedure using the CAD-eye detection and classification system, with input from the endoscopist in the case of serrated polyps, for patients who agree to undergo optical diagnosis of diminutive colorectal polyps.
Other: Autonomous AI-assisted classification
AI-assisted classification for diminutive polyps during a colonoscopy procedure using the CAD-eye detection and classification system, with no input from the endoscopist, for patients who agree to undergo optical diagnosis of diminutive colorectal polyps.
Related Therapeutic Areas
Sponsors
Leads: Daniel Von Renteln

This content was sourced from clinicaltrials.gov